Quality Management Senior Director
2 weeks ago
The Senior Director Quality Operations will play a critical role in ensuring the site's compliance with CGMP regulatory requirements. This includes leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.
Responsibilities:- Develop, implement, and maintain QA oversight activities to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
- Establish operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
- Lead the Quality Operations team to deliver exceptional performance of each assigned area.
- Perform QA review and approval of any associated deviations, CAPAs, and change controls.
- Dispose products that meet all requirements on time based on established commitments.
- Liaise with internal and external stakeholders to achieve expected business outcomes.
- 12+ years of team management experience.
- Bachelor's degree with 12+ years of relevant experience in a regulated pharmaceutical, biotechnology, or CDMO environment.
- 7+ years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
- Strong leadership, collaboration, team building, program management, and organizational skills.
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Senior Quality Operations Director
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob Summary:The Senior Director Quality Operations is responsible for ensuring the site's compliance with CGMP regulatory requirements. This includes leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.Key Responsibilities:Develop and implement QA...
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Director of Quality Assurance and Compliance
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeAbout the Job:The Senior Director Quality Operations will be responsible for leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.Key Accountabilities:Ensure products are manufactured to meet all CGMP regulatory requirements for phase-appropriate...
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Director of Quality Systems Management
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Director of Quality Systems Management is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. This role will include leading one or more PQS sub-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation. The ideal...
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QA - Director Quality Systems
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. Responsibilities will include one or more PQS sub-systems: Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, eQMS, and Quality...
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Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob SummaryThe Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. The position involves leading a team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external...
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Compliance and Quality Operations Manager
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob Description:The Senior Director Quality Operations will be responsible for ensuring the site's compliance with CGMP regulatory requirements. This includes leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.Responsibilities:Develop and...
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Director of Quality Assurance
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob Description:The Director Quality Systems will be responsible for overseeing the development, implementation, and maintenance of Pharmaceutical Quality Systems (PQS) for FDBT. This includes leading a team to create a strong quality culture, ensuring compliance with regulatory requirements, and aligning PQS sub-systems with harmonized global...
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Compliance and Quality Director
6 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeQuality Compliance LeaderFujifilm Holdings America Corporation is seeking a seasoned professional to serve as our Director of Quality Systems and Compliance. In this critical role, you will be responsible for developing and implementing quality systems and compliance strategies that meet regulatory requirements and support business objectives. If you are a...
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Quality Improvement Director
2 days ago
Hamilton, Waikato, New Zealand AUTOBAG® Brand Automated Systems Full timeJob DescriptionWe are seeking a Quality Improvement Director to join our team at AUTOBAG Brand Automated Systems. This is an exciting opportunity for a seasoned professional to drive quality improvement strategies and actions achieving continuous improvement in plant, customer quality and food safety performance.Key Responsibilities:Provide leadership in...
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Quality Control Director
2 weeks ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeAbout the Role:The Director Quality Systems will play a critical role in ensuring the effective development, implementation, and maintenance of Pharmaceutical Quality Systems (PQS) for FDBT. The ideal candidate will have expertise in Pharmaceutical Quality Systems, excellent communication skills, and the ability to lead a team to deliver exceptional...
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Quality Operations Manager
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob DescriptionWe are seeking an experienced Associate Director to lead our Quality Operations team at FDBT.About the RoleThis role will oversee QA oversight of cGMP operations and areas, lead a value stream under the guidance of the Sr Director Quality Operations, and ensure products meet all cGMP regulatory requirements.Key ResponsibilitiesDevelop,...
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Manufacturing Quality Director
1 week ago
Hamilton, Waikato, New Zealand Sealed Air Full timeAbout UsAt Sealed Air, we are committed to providing exceptional service to our customers while maintaining the highest levels of quality and efficiency. To achieve this goal, we are seeking a Manufacturing Quality Director to lead our quality improvement efforts and drive process excellence across our manufacturing operations.Job SummaryThe successful...
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Qa - Director Quality Compliance
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition OverviewThe Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.Responsibilities will include one or more PQS sub-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.Lead the assigned team to...
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Pharmaceutical Quality Assurance Director
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Summary:The Director of Pharmaceutical Quality Systems will develop, implement, and maintain individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. This role will also lead the Quality Compliance team to deliver exceptional performance of each assigned sub-system.Main Responsibilities:Develop and maintain risk-based PQS...
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Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob OverviewWe are seeking a highly experienced Senior Director of Pharmaceutical Compliance and Governance to lead our Quality Compliance team at Fujifilm Holdings America Corporation.The successful candidate will be responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. This...
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Director of Pharmaceutical Quality Systems
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Description:The Director of Pharmaceutical Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. This role will oversee one or more PQS sub-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and...
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Quality Compliance Lead
1 week ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeAbout the Role:We are seeking a highly skilled Director of Pharmaceutical Quality Systems to join our team at Fujifilm Diosynth Biotechnologies. The successful candidate will be responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.Key Responsibilities:Develop and implement...
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Senior Quality Excellence Manager
3 days ago
Hamilton, Waikato, New Zealand Sealed Air Full timeJob OverviewWe are seeking a highly skilled Senior Quality Excellence Manager to join our team at Sealed Air. As a key member of our site leadership team, you will be responsible for providing leadership in quality improvement methodologies and driving performance excellence across our manufacturing operations.Key ResponsibilitiesLeadership and Coaching:...
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Director of Quality Systems and Compliance
6 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeAbout UsFujifilm Holdings America Corporation is a leading healthcare and life sciences company that is dedicated to improving lives through innovation. Our commitment to quality and excellence has earned us a reputation as a trusted partner in the industry. We are proud to offer a dynamic and inclusive work environment that fosters growth and development...
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Director of Compliance and Quality Assurance
2 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeAbout the RoleThe Director Quality Systems will be responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. This includes leading a team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external...